Kornimate/medical-research-clean huggingface dataset:
glucose insulin potassium with intensive insulin therapy and (gik2) versus gik alone

Conditions: Acute Coronary Syndrome

Summary: the aim of this study is to evaluate the effect of the glucose insulin potassium (gik) infusion associated with intensive insulin therapy compared to gik alone and control group in patients presenting to the ed with acute coronary syndrome.

it is well recognised that diabetes is a factor of worse prognosis in acute coronary syndrome (acs). recently, the relationship between the glucidic metabolism and cardiac ischemia was highlighted whether patients have diabetes or not. indeed, it was established that hyperglycemia occurring during hospitalization in non diabetic patients, is a powerful risk factor of death. stress related hyperglycemia occurs during number of acute pathological situations (ami, stroke, pancreatitis, hypothermia, hypoxia, cirrhosis, polytrauma, burn, sepsis.... it is due to an excess of hyperglycemia hormones (glucagon, growth hormone, catecholamines and glucosteroids) and of inflammatory mediators (cytokines...). hyperglycemia has several deleterious effects on the cardiovascular system as it promotes microvascular inflammatory reaction, activation of the coagulation system, and free radical oxygen liberation. currently, the idea of controlling glycemia in surgical and medical intensive care patients is widely accepted and maintaining blood sugar level closest to normal by intensive insulin therapy became largely recommended. several decades ago, glucose-insulin-potassium infusion (gik) was proposed to protect acute cardiac ischemia. gik has been assessed in many previous studies. the results of these studies are contradictory. according to create-ecla study which is the largest (including 20201 patients), gik didn't show a significant beneficial effect in acs. however, in these trials using gik alone glycemia was not strictly controlled. recently, the importance of tight glycemic control has been highlighted in icu patients and early post heart surgery. our hypothesis is that gik treatment associated to intensive insulin therapy in acs would be beneficial and superior to gik alone possibly because intensive insulin therapy would prevent potential deleterious effects of hyperglycemia induced by gik.

Eligibility criteria:
inclusion criteria: * all patients fulfilling acs criteria with or without known diabetes. exclusion criteria: * patients under 18 years old. * killip ii class or sao2 ≤ 90%. * blood creatinine ≥ 180 µmol/l * potassium serum ≥ 6.5 mmol/l.

Keywords: acute coronary syndrome glucose insulin potassium
advanced imaging for radiotherapy treatment planning and guidance for low-intermediate risk prostate cancer (margin)

Conditions: Low or Intermediate Risk Prostate Cancer

Summary: the integration of magnetic resonance imaging (mri) in the treatment planning process for prostate cancer will reduce uncertainties in delineation of the prostate gland, and will enable delineation of the urethra, penile bulb, and internal pudendal artery. the integration of daily cone-beam computed tomography (cbct) will markedly reduce set-up uncertainties, thereby reducing the minimum planning target volume (ptv) margin. by combining mri simulation and daily cbct, and by adapting radiation delivery accordingly, the investigators will reduce dose delivered to the rectum, bladder, urethra, and erectile structures. in this study, the investigators seek to determine whether this dose reduction translates to improved patient outcomes. in a prospective, 2-stage design, up to 190 patients will be enrolled. in the first stage, advanced imaging will be integrated without altering dose planning techniques. stage 2 will reduce dose delivered to normal tissues, and will collect toxicity outcome measures. this clinical trial will be conducted over 3 years.

advances in medical imaging, and their integration in the treatment planning and daily guidance of radiotherapy, stand to improve the therapeutic ratio. improved imaging can reduce uncertainties by 1) improving the accuracy and reproducibility of organ or tumor delineation, and 2) guiding and adapting delivery to account for organ motion. this paradigm has been widely accepted in the radiotherapy community, and much research has addressed the technical and dosimetric aspects for a sound clinical implementation. however, direct evidence of a clinical translation to improved patient outcomes is limited. in this study, we hypothesize that the integration of advanced imaging for treatment planning and guidance will safely enable a reduction of dose delivered to normal tissues, and will improve toxicity and quality of life (qol) outcomes in patients receiving external beam radiotherapy for low or intermediate risk prostate cancer.

Eligibility criteria:
inclusion criteria: low or intermediate risk localized prostate cancer: * gleason score ≤ 7 * psa \<20 * stage t2a or less (stage 2 only) * \<50% of biopsy cores involved with tumor (stage 2 only) exclusion criteria: * history of hip replacement * inflammatory bowel disease or collagen vascular disease * contraindication to fiducial marker placement * bleeding diathesis or anticoagulant therapy that cannot safely be ceased temporarily * severe adverse event with prior trus-guided prostate biopsy * patient refuses fiducial marker placement * contraindication to mri * patient randomization in profit trial (stage 2 only) * patients not prescribed 78gy in 39 fractions to the prostate gland.

Keywords: prostate cancer magnetic resonance imaging
effect of ketamine added to intravenous patient-controlled analgesia on postoperative pain, nausea and vomiting in patients undergoing lumbar spinal surgery

Conditions: Postoperative Nausea and Vomiting

Summary: ketamine added to intravenous patient-controlled analgesia may be effective on prevention of postoperative nausea and vomiting by reducing opioid requirement after surgery.


Eligibility criteria:
inclusion criteria: * non-smoking female patients undergoing elective lumbar spinal surgery * age 20-65 * american society of anesthesiologists physical status classification i or ii exclusion criteria: * antiemetic within 24 hrs, taking steroids, opioids within 1 week * psychiatric disease, active drug or alcohol abuse * gi motility disorder, severe renal/ hepatic disease * insulin-dependent dm * admission to icu after surgery
genetic polymorphisms in ranibizumab treatment in wet age-related macular degeneration (amd)

Conditions: Age-Related Macular Degeneration

Summary: genetic factors of an individual patient may have an impact on ranibizumab (lucentis) treatment outcome in patients with wet age-related macular degeneration (amd).

age-related macular degeneration (amd) is a disease that affects central part of the retina, called macula, and is associated with progressive central vision loss. moreover, amd is known to be a leading cause of blindness in developed countries. in wet form of amd, new abnormal blood vessels start to grow from the choroid towards the retina that leads to leakage from these vessels and, in turn, to impaired retinal structure and rapid vision loss. genetic factors were found to be important in development of wet amd. our previous research showed the association between some genetic polymorphisms and the risk of wet amd as well as with specific clinical features of the disease. at present, anti-vascular endothelial growth factor (anti-vegf) therapy with intravitreous ranibizumab (lucentis) is considered to be the most effective treatment for wet amd. however, treatment outcomes may vary significantly from improved vision to no effect. the aim of this research is to study how ranibizumab treatment outcomes depend on genetic factors.

Eligibility criteria:
inclusion criteria: * patients must be at least 50 years old * neovascular age-related macular degeneration * cnv in the central part of the retina (macular is involved) * active cnm (seen on fundus fluorescein angiography) * cnv activity is on one of the following: sub-retinal hemorrhage, sub-retinal lipid, documented loss of 3 lines of vision during last 3 months * visual acuity of between 20/40 and 20/300 (etdrs) exclusion criteria: * patients under 50 years old * patients with cnm not caused by amd * patients physically unable to tolerate intravenous fluorescein angiography * patients with medically uncontrolled glaucoma * patients with history of bronchial asthma, thrombophlebitis, polyvalent allergy, cancer * any intraocular surgery within 3 months in the study eye * prior retinal or vitreous surgery including vitrectomy or scleral buckling * any significant ocular disease other than amd that has compromised or could compromise vision in the study eye and confound analysis of the primary outcome * individuals with physical or mental disabilities that prevent accurate vision testing * history of any laser treatment of cnv in study eye (laser photocoagulation or prior photodynamic therapy), or anti-vegf (ranibizumab or bevacizumab) in the past 2 years in the study eye.

Keywords: wet amd genetic polymorphisms ranibizumab
contribution of esaote™ low field mri for diagnosis of scaphoid fractures

Conditions: Scaphoid Bone Fracture Suspicion

Summary: the alpes maritimes county administration (france) equipped nice university hospital of a 0,2t low field mri dedicated to distal articulations, devoted to research, installed in the medical imaging unit. the aim of our project is to study its interest in diagnosis of scaphoid fractures. conventional medical care for patients being suspected to have a scaphoid fracture consists in performing a clinical examination and a radiographic check-up with at least 4 incidences, which 2 specific incidences for the scaphoid bone. yet, this check up is sometimes defective, causing false positives unnecessary immobilisation and false negatives delays in patient medical care, increasing the risk of complication. those diagnosis mistakes can bring serious consequences, from permanent partial inability, to professional reclassification. alternative imaging exists, but is often irradiating, and never reaches the optimal specificity and sensitivity. mri is totally safe, and allows to affirm or invalidate the diagnosis in almost 100% of cases. the problem is the lack of accessibility for emergency cases; therefore there is a great interest in validating the use of a mri dedicated to distal articulations. the few studies that study costs of diagnosis strategies including mri in scaphoid bone fractures diagnosis show a reduction of medical costs if this technique is used early. our project represents an essential initial step in evaluating the impact of a low field mri dedicated to peripheral articulations in diagnosis of scaphoid fractures. the next step will be a medico-economical study, since scaphoid fractures occur frequently. finally, a new consensus for medical care of scaphoid fracture suspicions could be proposed.


Eligibility criteria:
inclusion criteria: * clinical suspicion of scaphoid bone fracture, whatever the radiologic check-up result is. * major patient who signed the informed consent form. * patient affiliated to french national health and pensions organization. non inclusion * mri contraindication. * no pain. * no traumatic antecedent. * pregnant or suckler women. * patient under a guardianship or a trusteeship * patient deprived of liberty consequently to a judiciary procedure * patient holding a pace-maker * patient holding a foreign body or ferromagnetic prosthetic material.

Keywords: scaphoid mri esaote
comparison between two techniques to reposition the maxilla after le fort 1

Conditions: Dentofacial Deformities; Le Fort; I

Summary: clinical and radiographic comparison between novel locating guide design with pre-bent titanium plates and 3d printed intermediate wafer to reposition the maxilla after le fort 1 osteotomy in orthognathic surgery (randomized controlled clinical trial)

eligible patients will be allocated randomly into 2 equal groups with 7 patients in each group according to the method that will be used to reposition the maxilla by simple randomization using computer generated random numbers. group 1 (study group) will be treated with locating guides to reposition the maxilla with pre-bent plates on 3d model. group 2 (control group) will be treated with intermediate wafer.

Eligibility criteria:
inclusion criteria: * all patients requiring le fort i osteotomy will be selected including those suffering from skeletal malocclusion (class ii or class iii), midface hypoplasia or vertical maxillary excess. exclusion criteria: cleft lip and palate. skeletal disharmony due to trauma or severe facial asymmetry. significant medical condition.

Keywords: orthognathic virtual planning
mass evaluation of lateral flow immunoassays for the detection of sars-cov-2 (covid-19) antibodies

Conditions: Solid Organ Transplant Recipients; Autoimmune Diseases; Haematological Malignancies

Summary: design observational epidemiological study aims - to determine: 1. the proportion of immunosuppressed people who have detectable sars-cov-2 antibodies following a primary vaccine course (3 doses), and the demographic, disease, and treatment characteristics that influence antibody status. 2. if the detection of antibodies inversely correlates with subsequent risk of severe acute respiratory syndrome coronavirus-2 infection and/or severity of disease in immunosuppressed people.

the aim of this proposal is to assess at a population level; 1) the proportion of immunosuppressed people who have detectable sars-cov-2 antibodies following a primary vaccine course (3 doses), and the sociodemographic, disease, and treatment characteristics that influence antibody status; 2) if the detection of antibodies inversely correlates with subsequent risk of sars-cov2 infection and/or severity of disease in immunosuppressed individuals. the investigators aim to target patient groups least likely to mount an immune response to vaccination; a) solid organ transplant recipients; b) patients with a rare autoimmune disease c) patients with haematological malignancies, specifically lymphoid malignancies. the investigators will use comprehensive registries to identify and recruit patients from these groups, and utilise the existing linkages these registries already have to obtain covid-19 outcome information. the investigators hypothesise that a sizeable proportion of immunosuppressed people will have no detectable sars-cov-2 antibodies following a three vaccine doses, and that this cohort is particularly susceptible to sars-cov-2 infection and death.

Eligibility criteria:
inclusion criteria: adults and young people over 12 years of age, and are classified as being part of one of the following patient groups: 1. a solid organ transplant recipient (n=12,000) 2. patients with a rare autoimmune disease (n=12,000) 3. patients with lymphoid malignancies (n=12,000) - exclusion criteria: -

Keywords: antibody testing sars-cov-2 covid-19 immunosuppression solid organ transplant haematological malignancy blood cancer autoimmune disease
intravesical instillation of botulinum toxin type a to patients with urge urinary incontinence

Conditions: Urge Urinary Incontinence

Summary: a pilot study to examine efficacy and safety of intravesical botulinum toxin type a.


Eligibility criteria:
inclusion criteria: * refractory urge urinary incontinence exclusion criteria: * neurological disease * pregnant or lactating * bladder neoplasias
an observational study to assess change in disease activity and adverse events of upadacitinib in adult participants with moderate to severe ulcerative colitis (uc) in real-world practice

Conditions: Ulcerative Colitis

Summary: ulcerative colitis (uc) is an idiopathic, chronic, inflammatory disease affecting the colon. participants with uc have mucosal inflammation starting in the rectum that can extend continuously to proximal segments of the colon. this study will assess how safe and effective upadacitinib is in treating adult participants with moderate to severe ulcerative colitis (uc). adverse events and change in disease activity will be assessed. upadacitinib is a drug approved for the treatment of ulcerative colitis (uc). all study participants will receive upadacitinib as prescribed by their study doctor in accordance with approved local label. approximately 1000 adult participants will be enrolled worldwide. participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. participants will be followed for up to 3 years. there is expected to be no additional burden for participants in this trial. participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.


Eligibility criteria:
inclusion criteria: * participants with a diagnosis of moderate to severe ulcerative colitis (uc). * participants initiating upadacitinib at the clinician's discretion as part of their routine clinical care; the decision to administer upadacitinib must be made prior to and independent of recruitment into the study. * participants prescribed upadacitinib in accordance with the approved local label. * participants able to understand and communicate with the investigator and comply with the requirements of the study. * participants willing to continue with study documentation after cessation of upadacitinib. * participants willing and able to participate in the collection of patient-reported data via cloud based mobile application using the provided smart device (iphone). exclusion criteria: * participants with any contraindication to upadacitinib. * participants previously exposed to upadacitinib in a clinical trial. * participants currently participating in interventional research (not including noninterventional study, postmarketing observational study (pmos), or registry participation).

Keywords: ulcerative colitis upadacitinib profundus rinvoq
assessment of cardiac functional reserve in heart failure with preserved ejection fraction (hf-pef)

Conditions: Heart Failure

Summary: this study will compare the ability of the heart to increase its contractile performance during stress in patients with a history of heart failure without systolic dysfunction and in controls.

there will be two groups of 20 subjects recruited in a collaborative effort by uwhc and university of pennsylvania. this project will require one visit approximately 3-5 hours in length. the subject will fill out a symptom questionnaire. a small gauge angiocath will be place to establish intravenous access. single-lead ecg and blood pressure are monitored for the duration of the protocol. tonometry (non-invasive measurement of the pulse) and echocardiographic images will be obtained at baseline. after baseline data are obtained, dobutamine will be infused at escalating doses of 2, 4, 8, and 16 µg/kg/min iv at ≤30-minute intervals. after 5 minutes of infusion at each dose, echocardiographic and tonometry data will be recorded. if 85% or more of predicted target heart rate is reached, the final study data collection and safety imaging will be performed and the dose not increased further.

Eligibility criteria:
inclusion criteria: * mentally stable and willing to give informed consent * sinus rhythm on resting ecg * systolic blood pressure \> 90 mmhg * ejection fraction \> 45% assessed within the last year * stable heart failure for at least one month prior to study exclusion criteria: * unstable angina or hemodynamic instability * known severe coronary artery disease without surgical or percutaneous revascularization * angina pectoris with usual activities * history of myocardial infarction in the previous six months, significant valvular abnormalities, pulmonary hypertension, copd or pulmonary emboli, intracardiac thrombus, sustained ventricular tachycardia induced by dobutamine in the past, or known allergy or other intolerance to dobutamine * uncontrolled hypertension * pregnant women * permanent pacemaker with pacemaker dependency * known poor echocardiographic images

Keywords: heart failure with preserved ejection fraction
enhanced recovery protocols in gynecologic oncology

Conditions: ERAS; Gynecologic Cancer; Perioperative Complication; Postoperative Pain; Quality of Life; Infections

Summary: enhanced recovery after surgery (eras) are developed to provide a systematic structure for managing postsurgical patients.these protocols promote evidenced-based practices and implement a multidisciplinary effort to maintain normal physiology in the perioperative period and aid in earlier recovery. the present study aims to investigate the feasibility of and compliance to a structured eras protocol among gynecological oncological centers in greece as well as to compare the outcomes among patients that fullfilled the minimum number of necessary criteria, compared to those that were enrolled in eras protocols but did not meet the sufficient necessary criteria.

enhanced recovery after surgery (eras) are developed to provide a systematic structure for managing postsurgical patients.these protocols promote evidenced-based practices and implement a multidisciplinary effort to maintain normal physiology in the perioperative period and aid in earlier recovery. eras protocols briefly include pre-admission education, pre-operative nutritional care, specific recommendations for pre-operative medications, a standardized anesthetic protocol, perioperative fluid management, multimodal analgesia (mma), early mobilization, and early removal of urinary catheters. ergo study study aims to investigate the feasibility of and compliance to a structured eras protocol among gynecological oncological centers in greece as well as to compare the outcomes among patients that fullfilled the minimum number of necessary criteria, compared to those that were enrolled in eras protocols but did not meet the sufficient necessary criteria. patients will be registered into the trial before surgery. quality assurance program will be in place for both patients that will fulfill the eras criteria as well as for those that will not fulfill them.

Eligibility criteria:
inclusion criteria: patients with gynaecological cancer and an ecog performance status \<4, asa score \<4. exclusion criteria: patients with metastatic cancer of non-gynaecological origin patients that are not able to follow eras protocol due to medical reasons patients with severe debilitating comorbidities (ecog status 4, asa score 4-5)